Diabetes Mellitus, Type 2 study: CagriSema
Official title A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 Diabetes
ClinicalTrials.gov ID: NCT07282613
What this study is testing
What is CagriSema?
an investigational once‑weekly injectable medicine being studied as a potential treatment for type 2 diabetes in children and adolescents is designed to activate GLP‑1 and amylin receptors to help lower blood sugar and reduce body weight
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see how well CagriSema helps children and teens with type 2 diabetes control blood sugar and reduce weight.
- Who it's for
- Children and adolescents with type 2 diabetes.
- What's involved
- Participants will receive either CagriSema or a placebo for the first part of the study, then all will receive CagriSema in the second part. They will have regular visits and tests to monitor blood sugar and weight.
- Time commitment
- The study lasts about 1 year and 3 months, with multiple clinic visits throughout that time.
- Phase 3: a large, late-stage study
- Time commitment: about 1 year
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 18
You may be able to join if
- Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any...
- The parent(s) or LAR of the child must sign and date the Informed Consent Form (according to local requirements)
- The child must sign and date the Child Assent Form or provide oral assent (according to local requirements)
- Male or female.
- Age 10 to \< 18 years at the time of signing the informed consent.
You likely can't join if
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive...
- Treatment with any antidiabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days...
- Known or previous diagnosis of hypoparathyroidism.
- Previous or planned (during the study period) obesity treatment with surgery or a weight loss device.
- Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies as determined by central...
- Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
See the full eligibility criteria
- Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study-related activities.
- The parent(s) or LAR of the child must sign and date the Informed Consent Form (according to local requirements)
- The child must sign and date the Child Assent Form or provide oral assent (according to local requirements)
- Male or female.
- Age 10 to \< 18 years at the time of signing the informed consent.
- Diagnosed with T2D (according to the latest International Society for Pediatric and Adolescent Diabetes [ISPAD] criteria) ≥ 30 days before screening.
- Insulin (any regimen)
- Metformin
- SGLT2i
- HbA1c 6.5%-11.0% (48 mmol/mol - 97 mmol/mol) (both inclusive) as determined by central laboratory at screening.
- Body weight ≥ 45 kg and BMI ≥ 85th percentile(b). BMI will be calculated in the electronic case report form based on height and body weight at screening.
- (a) For metformin, a stable dose is defined as at least 1000 mg daily or the maximum tolerated dose for ≥ 56 days prior to screening.
- (b) Based on sex-specific BMI-for-age percentiles for the given country or region. If not available for the country or region, the respective charts or tables on cdc.gov may be used. Key
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
- Treatment with any antidiabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening.
- Known or previous diagnosis of hypoparathyroidism.
- Previous or planned (during the study period) obesity treatment with surgery or a weight loss device.
- Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies as determined by central laboratory at screening or in medical history.
- Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
- Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
- Uncontrolled and potentially unstable diabetic retinopathy maculopathy. Verified by a fundus examination and optical coherence tomography (OCT) assessment performed within 90 days before screening or in the period...
The study team makes the final eligibility decision.
Where it is enrolling
- Boynton Beach, Florida, United States
- Jacksonville, Florida, United States
- Kissimmee, Florida, United States
- Tamarac, Florida, United States
- Tampa, Florida, United States
- Columbus, Georgia, United States
- Snellville, Georgia, United States
- Iowa City, Iowa, United States
- Southfield, Michigan, United States
- Memphis, Tennessee, United States
- Houston, Texas, United States
- Shavano Park, Texas, United States
- Charlottesville, Virginia, United States
- Seattle, Washington, United States
- Capital Federal, Buenos Aires, Argentina
- San Miguel de Tucumán, Tucumán Province, Argentina
- City of Buenos Aires, Argentina
- San Miguel de Tucumán, Argentina
- Bairro Rodolfo Teófilo, Fortaleza, Ceará, Brazil
- Curitiba, Paraná, Brazil
+ 9 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boynton Beach, Florida, United States; Jacksonville, Florida, United States; Kissimmee, Florida, United States; Tamarac, Florida, United States; Tampa, Florida, United States; Columbus, Georgia, United States and 23 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.